A multi-centre, open-label, phase II study of the safety, efficacy and pharmacokinetic (PK) profile of CAP-232 administered through continuous intravenous infusion in patients with metastatic kidney cancer

Caprion Pharmaceuticals Inc.0 个研究点目标入组 40 人开始时间: 2006年11月28日最近更新: 2012年3月19日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 40

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1) Patients must have histologically confirmed stage IV kidney clear cell carcinoma.
•2) Patients must have progressive disease after receiving a previous systemic therapy.
•3) Patient must have progressive disease confirmed by 2 CT Scans or MRI performed within 6 months.
•4) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
•5) Patients must have an age >18 years.
•6) Patients must have life expectancy of greater than 3 months.
•7) Patient must be at least 5 years free of any other cancer(s). Basal cell carcinoma, provided that is neither infiltrating nor sclerosing and carcinoma in situ of the cervix, is acceptable.
•8) Patients must have ECOG performance status ? ?2 (Karnofsky 60%).
•9) Patients must have normal organ and marrow function as defined below:
•Leukocytes >3,000/mm3
•Absolute neutrophil count >1,500/mm3
•Platelets >100,000/ mm3
•Total bilirubin within normal institutional limits
•AST(SGOT)/ALT(SGPT) ?2.5 X institutional upper limit of normal
•Calculated creatinine clearance >30 mL/min/1.73 m2
•10) Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
•11) Patients or the patient’s legal guardian must be able to understand and have the willingness to sign a written informed consent document.
•12) Patients must have the ability to receive central vein access catheter and manage an infusion pump.
•13) Women of child bearing potential must have a negative serum pregnancy test.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•11) Patients who have received any known medical treatment targeting cancer within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
•2) Patients may not be receiving any other investigational agents at least 30 days prior to enrollment in the study or/and participate in another clinical trial.
•3) Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
•4) Patients with a history of allergic reactions attributed to compounds of similar composition to CAP-232. CAP-232 consists of a heptapeptide (active ingredient) in an acetate buffered saline solution with mannitol (0.2 M sodium acetate, 0.2 M acetic acid, 3% mannitol).
•5) Patient with past or current cancer other than kidney cancer, except for:
•Curatively treated non-melanoma skin cancer
•In situ carcinoma of the cervix
•Other cancer curatively treated and with no evidence of disease for at least 10 years
•6) Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•7) Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAP-232, breastfeeding should be discontinued if the mother is treated with CAP-232.
•8) Patients that have previously been enrolled into this study and subsequently withdrawn must also be excluded.

研究者

发起方

Caprion Pharmaceuticals Inc.

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